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Monday, July 27, 2015
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a positive
opinion recommending approval of the investigational antibiotic ZERBAXA™
(ceftolozane and tazobactam) for the treatment of the following
infections in adults: complicated intra-abdominal infections, acute
pyelonephritis, and complicated urinary tract infections.
The CHMP positive opinion will be reviewed by the European Commission. Nimotop (Nimodipine) with free Rx
If the European Commission affirms the CHMP opinion, it will grant a
centralized marketing authorization with unified labeling that is valid
in the 28 countries that are members of the European Union, as well as
European Economic Area members, Iceland, Liechtenstein and Norway.
About ZERBAXA
ZERBAXA (ceftolozane and tazobactam) for injection (1.5 g) is an
antibacterial combination product for intravenous infusion consisting of
the cephalosporin antibacterial drug ceftolozane sulfate and the
beta-lactamase inhibitor tazobactam sodium.
ZERBAXA is approved in the United States and is indicated in adult
patients for the treatment of complicated urinary tract infections
(cUTI), including pyelonephritis, caused by the following Gram-negative
microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus
mirabilis, and Pseudomonas aeruginosa. About Kamagra Oral Jelly (Sildenafil Citrate) with no prescription ZERBAXA used in
combination with metronidazole is indicated in adult patients for the
treatment of complicated intra-abdominal infections (cIAI) caused by the
following Gram-negative and Gram-positive microorganisms: Enterobacter
cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella
pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides
fragilis, Streptococcus anginosus, Streptococcus
constellatus, and Streptococcus salivarius.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZERBAXA (ceftolozane and tazobactam) and other
antibacterial drugs, ZERBAXA should be used only to treat infections
that are proven or strongly suspected to be caused by susceptible
bacteria. About Plan B (Levonorgestrel) with no prescription When culture and susceptibility information are available,
they should be considered in selecting or modifying antibacterial
therapy. About Dorzox In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of
therapy.
Important Safety Information about ZERBAXA
Patients with renal impairment: Decreased efficacy of ZERBAXA has
been observed in patients with baseline CrCl of 30 to =50 mL/min had a clinical
cure rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9%
when treated with meropenem. About Tadalis SX (Tadalafil) without prescription In the same trial, patients with CrCl 30 to
=5% of patients were headache (5.8%) in the cUTI trial, and nausea
(7.9%), diarrhea (6.2%) and pyrexia (5.6%) in the cIAI trial.
About Merck
Today s Merck is a global healthcare leader working to help the world be
well. Buy Walnut Oil online Merck is known as MSD outside of the United States and Canada. http://webmdmagazine.wordpress.com
Through our prescription medicines, vaccines, biologic therapies and
animal health products, we work with customers and operate in more than
140 countries to deliver innovative health solutions. We also
demonstrate our commitment to increasing access to healthcare through
far-reaching policies, programs and partnerships. For more information,
visit .merck.com
and connect with us on Twitter,
Facebook
and YouTube.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing difficulties
or delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in the company’s 2014 Annual Report on Form 10-K
and the company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (.sec.gov).
Please see Prescribing Information for ZERBAXA (ceftolozane and
tazobactam) at zerbaxa.com/pdf/PrescribingInformation.pdf.
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